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Aesculap KY202R

by Aesculap, Inc.

Part of a family of 6 devices: see the family page

Ref KY202R

Aesculap KY202R is a device classified as Class IIa in the EU and Class I in the US made by Aesculap, Inc., registered in EUDAMED on 18 Nov 2025 (Basic UDI-DI 40392390000006502C) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653174676), active (EUDAMED), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000006502C Basic UDI-DI 04038653174676UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653174676 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000006502C registered 18 Nov 2025 Active
  • FDA GUDID UDI-DI 04038653174676 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653174676
  2. Registered EUDAMED 40392390000006502C

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Aesculap
Generic name
Wire/ligature passer, reusable
Device name
Cerclage instrument
Model / Ref / Catalog
KY202R
Primary DI / UDI-DI
04038653174676
Basic UDI-DI
40392390000006502C
Direct marketing DI
04038653174676
FDA product code
HXN
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Wire/ligature passer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)